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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Acid, Folic, Radioimmunoassay
510(k) Number K932887
Device Name ACCESS FOLATE ASSAY
Applicant
Beckman Coulter, Inc.
200 S. Kraemer Blvd.,M/S W-104
Box 8000
Brea,  CA  92822
Applicant Contact KIM WALKER
Correspondent
Beckman Coulter, Inc.
200 S. Kraemer Blvd.,M/S W-104
Box 8000
Brea,  CA  92822
Correspondent Contact KIM WALKER
Regulation Number862.1295
Classification Product Code
CGN  
Date Received06/14/1993
Decision Date 10/12/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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